Regulatory Affairs Specialist

Profile

3 openings. One is more focused on publishing and the other two are described here:
The Specialist/Manager Regulatory Operations contributes to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for his/her assigned products and/or therapeutic area(s) in collaboration with other departmental representatives.
The Specialist/Manager Regulatory Operations is responsible for the scheduling, timelines, follow-up, and preparation of all IND/NDA Annual Reports, Amendments, Briefing Documents and other periodic submissions in support of regulatory filings to regulatory agencies. He/she works closely with intra-departmental and cross-functional teams. He/she also oversees the document acquisition process and storage/filing of draft and final documents.
The Specialist/Manager Regulatory Operations contributes to special projects and/or initiatives as assigned.
KEY RESPONSIBILITIES: (Provide 7 to 10 primary activities)
X Prepare (e.g.: write, compile, organize, assembly, and transcribe) applicable information and data for IND and/or NDA applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing documents and general correspondence for all assigned clinical development and/or marketed products for submission to regulatory agencies.
X Provide guidance and support for organization, formatting, and structure of assigned regulatory submissions (IND, NDA) for assigned products and/or therapeutic area(s).
X Support the scheduling and timelines of major regulatory submissions.
X Act as contact for collection of required documents from participating departments, and distribution of those documents for review and approval by Regulatory Affairs management.
X Provide regulatory support to other MTDA departments and multi-functional teams to ensure compliance with regulatory requirements for content and format of paper/electronic regulatory submissions and documentation.
X Ensure the accuracy and completeness of electronic and hard copy regulatory files.
X Provide support during interactions with regulatory agencies reviewing submission content.
X Contributes to process improvement initiatives across the organization.
X Assists with other regulatory activities as required.
X Minimum BA/BS or equivalent work experience in life science or closely related field.
X Minimum of three (3) years direct experience with regulatory submissions in the pharmaceutical industry
X Level of position (Specialist or Manager) will be determined based on candidates education and experience
X Working knowledge of computer software, including advanced MS Word features.
X Experience with publishing tools and electronic document management systems as used within the pharmaceutical industry.
X Strong problem solving skills. Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail.
X Strong interpersonal and communication skills and ability to collaborate effectively with other groups in a matrix organization.
LOGIXtech Solutions
379 Thornall Street 6th Floor
Edison, NJ 08820
Web: ****

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